NCT00533962

Brief Summary

Introduction: Ocular administration of glucocorticoids is a common and effective treatment for several ocular diseases. However it is often complicated with the elevation of intraocular pressure (IOP). Anecortave acetate (AA) is an analog of cortisol acetate and lacks the typical anti-inflammatory and immunosuppressive properties of glucocorticoids. The effect of its anterior juxtascleral depot (AJD) injection has been evaluated in cases of glaucoma caused by intravitreal triamcinolone acetonide, presenting impressive results. The purpose of this study is to evaluate the efficacy and safety of the AA injection as a possible antiglaucoma treatment alternative. Methods: A prospective clinical study will be carried out including 30 glaucoma patients (30 eyes). After inclusion each patient will receive a single AJD injection of 30 mg of AA in the selected eye. Main outcome measure include: intraocular pressure at 1st day, 7th day, 1st, 2nd and 3rd months.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

September 20, 2007

Last Update Submit

September 21, 2007

Conditions

GlaucomaIntraocular Pressure

Keywords

GlaucomaAnecortave AcetateIntraocular pressureAdvanced glaucoma cases with uncontrolled IOP

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    Procedure

Secondary Outcomes (1)

  • Visual Acuity; side effects (biomicroscopy exam)

    Post treatment

Interventions

Anterior Juxtascleral Depot of Anecortave AcetateDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced glaucoma cases with surgery or cyclophotocoagulation indication (IOP over 25 mmHg)
  • Patients should be under maximum tolerated medication
  • Low best corrected visual acuity (worse than 20/100)

You may not qualify if:

  • Under 18 or over 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São Paulo

São Paulo, São Paulo, 01404-001, Brazil

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Tiago Prata

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 24, 2007

Study Start

August 1, 2007

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations

BR(1)